# FDA recall D-1446-2016

> **Sun Pharmaceutical Industries, Inc.** · Class III · drug recall initiated 2016-06-27.

## Product

buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries, Inc.   Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol 389-350 Gujarat India ---- NDC  47335-737-86

## Reason for recall

Failed Dissolution Specifications

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1446-2016
- **Recalling firm:** Sun Pharmaceutical Industries, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-06-27
- **Report date:** 2016-07-27
- **Termination date:** 2018-03-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cranbury, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1446-2016

## Citation

> AI Analytics. FDA recall D-1446-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-1446-2016. Source: US FDA. Licensed CC0.

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